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DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS

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About the medicine

How to use DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DONEPEZILO COMBIX 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read the package leaflet carefully before starting to take the medicine.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
  • If you experience any of the side effects, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

  1. What is DONEPEZILO COMBIX and what is it used for
  2. Before taking DONEPEZILO COMBIX
  3. How to take DONEPEZILO COMBIX
  4. Possible side effects
  5. Storage of DONEPEZILO COMBIX
  6. Further information

1. What is Donepezilo Combix and what is it used for

Donepezilo Combix belongs to a group of medicines called acetylcholinesterase inhibitors. They are used to treat the symptoms of Alzheimer's disease of mild to moderate severity. It should only be used in adult patients.

Doctor consultation

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2. Before taking Donepezilo Combix

Do not take DONEPEZILO COMBIX

  • If you are allergic to donepezil hydrochloride or any of the components of Donepezilo Combix.
  • If you are pregnant or breastfeeding.

Be careful with DONEPEZILO COMBIX

  • Before starting treatment with Donepezilo Combix, you should inform your doctor if you have or have a history of stomach ulcers, heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction), seizures, asthma, chronic pulmonary disease, or difficulty urinating, a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if someone in your family has "prolonged QT interval", or low levels of magnesium or potassium in the blood.
  • In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezilo Combix.
  • The use of Donepezilo Combix is not recommended in children.
  • You should avoid taking Donepezilo Combix with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
  • If you have vascular dementia (loss of brain function due to a series of small strokes).

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, especially if you are taking any of the following medicines:

  • Medicines for heart rhythm problems, such as amiodarone or sotalol
  • Medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
  • Medicines for psychosis, such as pimozide, sertindole, or ziprasidone
  • Medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
  • Antifungal medicines, such as ketoconazole
  • Quinidine and beta-blockers (to treat irregular heartbeats)
  • Rifampicin (to treat bacterial infections and tuberculosis)
  • Phenytoin and carbamazepine (to treat epilepsy)
  • Cholinergic agonists and medicines with anticholinergic activity (with action on the central nervous system)
  • Succinylcholine and other neuromuscular blockers (to produce muscle relaxation)

Taking Donepezilo Combix with alcohol may reduce the absorption of this medicine.

Taking DONEPEZILO COMBIX with food and drinks

This medicine should be taken with a little water.

Pediatric population:

The use of Donepezilo Combix is not recommended in children.

Pregnancy and breastfeeding

Do not take Donepezilo Combix if you are pregnant.

Do not take Donepezilo Combix if you are breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not perform these activities unless your doctor tells you it is safe to do so. Donepezilo may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Important information about some of the components of DONEPEZILO COMBIX

Donepezilo Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Donepezilo Combix

Follow the instructions for taking Donepezilo Combix exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Donepezilo Combix is administered orally.

Treatment with Donepezilo Combix starts with a 5 mg tablet, taken once a day with a little water, at night immediately before bedtime. After a month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo Combix in the morning.

If you have mild or moderate liver or kidney impairment, you can follow a similar dosage regimen as indicated above.

If you take more DONEPEZILO COMBIX than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take DONEPEZILO COMBIX

Do not take a double dose to make up for the forgotten dose.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Donepezilo Combix can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you notice any of these serious side effects. You may need urgent medical treatment.

  • Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction, which can be fatal and cause kidney problems (a disease called rhabdomyolysis).

Very common side effects (may affect more than 1 in 10 patients):

  • diarrhea.
  • nausea.
  • headache.

Common side effects (may affect between 1 and 10 in 100 patients):

  • common cold.
  • loss of appetite.
  • hallucinations, aggressive behavior, restlessness, which have been resolved by reducing the dose or interrupting treatment.
  • dizziness, insomnia, fainting.
  • vomiting, abdominal discomfort.
  • itching, rash.
  • muscle cramps.
  • urinary incontinence.
  • fatigue, pain.
  • accidents.

Uncommon side effects (may affect between 1 and 10 in 1,000 patients):

  • seizures.
  • slow heart rate.
  • gastrointestinal bleeding, stomach and duodenal ulcers.
  • in blood tests, a slight increase in the muscle enzyme creatine kinase.

Rare side effects (may affect between 1 and 10 in 10,000 patients):

  • rigidity or uncontrolled movements, especially of the face and tongue, but also of the limbs.
  • cardiac disorders.
  • liver disorders, including hepatitis.

Frequency not known

  • changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolonged QT interval"
  • fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes
  • Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)
  • increased libido, hypersexuality.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezilo Combix

Keep out of the reach and sight of children.

Do not use Donepezilo Combix after the expiry date stated on the blister and carton. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of DONEPEZILO COMBIX

  • The active ingredient is donepezil hydrochloride. Each film-coated tablet contains 5 mg of donepezil hydrochloride.
  • The other ingredients are:

Core of the tablet: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide E171, macrogol 400, talc E553b.

Appearance of the product and packaging contents

Donepezilo Combix 5 mg is presented in packs containing 28 film-coated tablets, white or almost white, round, biconvex, marked with "ZF9" on one side and smooth on the other.

Donepezilo Combix is also available in 10 mg film-coated tablets, in packs of 28 tablets.

Marketing authorization holder

LABORATORIOS COMBIX, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid), Spain

Manufacturer

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Zydus France

ZAC Les Hautes Patures

25 Rue des Peupliers

92000 Nanterre

France

Date of the last revision of this package leaflet:November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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Frequently Asked Questions

Is a prescription required for DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS?
DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS?
The active ingredient in DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS is donepezil. This information helps identify medicines with the same composition but different brand names.
Who manufactures DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS?
DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS is manufactured by Laboratorios Combix S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to DONEPEZIL COMBIX 5 mg FILM-COATED TABLETS?
Other medicines with the same active substance (donepezil) include ARICEPT 10 mg FILM-COATED TABLETS, ARICEPT 5 mg FILM-COATED TABLETS, ARICEPT FLAS 10 mg ORALLY DISINTEGRATING TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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